Global Regulatory Strategy and Market Access Planning
Practical RA provides global regulatory strategy support to help manufacturers plan coordinated market access across multiple jurisdictions.
Why Global Regulatory Strategy Matters
Manufacturers increasingly pursue simultaneous or staged entry into multiple regulated markets. While regulatory frameworks differ, many requirements overlap, particularly in areas such as risk management, clinical evidence, and post-market surveillance. Without coordinated planning, manufacturers often duplicate work, generate unnecessary data, or encounter conflicting regulatory expectations.
A global regulatory strategy considers how evidence generated for one market can support submissions in others, while recognising where jurisdiction-specific requirements apply. It also addresses sequencing decisions, such as whether to pursue EU, US, or Australian approvals first, and how regulatory feedback in one market may influence activities elsewhere.
Global strategy is particularly important for overseas manufacturers entering Australia, where appointment of an Australian Sponsor is required. Regulatory planning should account for Sponsor responsibilities, ARTG inclusion pathways, and alignment with EU and FDA documentation.
Effective global regulatory strategy supports efficient resource use, predictable timelines, and reduced regulatory risk across markets.
How Practical RA Can Support
Practical RA supports global regulatory strategy through:
- Cross-market regulatory pathway planning
- Submission sequencing and dependency analysis
- Alignment of documentation and evidence generation
- Integration of Australian Sponsor requirements
- Portfolio-level regulatory planning
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
